MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE); SIMILAR DEVICE NS7TBL174HS, PMA # P990025

Model Number D-1184-00

Device Problem Low impedance (2285)

Patient Problem No Code Available (3191)

Event Date 10/10/2014

Event Type  Injury  

Event Description

It was reported that 2 days after an afib ¿ paroxysmal procedure which was occurred on (b)(6) 2014, the patient developed pericarditis and a pericardial tap was performed.During and after the procedure, the patient was stable, no abnormalities were noted on ice.The patient required extended hospitalization because of the adverse event.It was stated that the physician couldn't see the impedance dropped because there was impedance noise on the carto 3 system and on the recording system.The physicians opinion on the cause of this adverse event was the procedure and patient condition.

Manufacturer Narrative

Bwi equipment involved: carto3 sn: (b)(4).

• Type of Device: SIMILAR DEVICE NS7TBL174HS, PMA # P990025
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4241981
• MDR Text Key: 5012318
• Report Number: 2029046-2014-00421
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1184-00
• Device Lot Number: UNKNOWN_NAVISTAR THR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR